Methods and systems for determining physiologic characteristics for treatment of the esophagus

• US 20070100333A1
• Filed: 12/04/2006
• Published: 05/03/2007
• Est. Priority Date: 11/16/1999
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: BARRX Medical LLC
• Inventors: Jackson, Jerome, Stern, Roger
• Granted Patent: US 7,993,336 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00482 Digestive system
• CPC Class Codes: A61B 2018/00488 Esophagus
• CPC Class Codes: A61B 2018/00494 Stomach, intestines or bowel
• CPC Class Codes: A61B 2018/00553 Sphincter
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00738 Depth, e.g. depth of ablation
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 5/037 Measuring oesophageal pressure
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/4233 : oesophagus
• CPC Class Codes: A61B 5/6885 : Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia

Abstract

A system for measuring physiologic characteristics for treating abnormal mucosa in the esophagus comprises a sizing device having an inflatable balloon on a distal end of a catheter that is inflated with an expansion medium to expand the balloon to engage the wall of the esophagus so that the internal cross-section can be calculated or measured. The sizing device may also include an infusion source for delivering the expansion medium and means for measuring the amount and pressure of the expansion medium inside the catheter. The system also comprises one or more energy delivery devices for injuring or ablating the

Claims

1. A method for treating the esophagus at a treatment location, the method comprising:

introducing an expandable sizing member at the treatment location within the esophagus;

substantially unfolding surface contours of a wall of the esophagous at the treatment location by expanding the sizing member;

measuring a substantially unfolded esophageal luminal dimension at the treatment location;

selecting an electrode structure with a pre-selected deployed state which corresponds to the measured esophageal luminal dimension;

introducing and deploying the selected electrode structure to the pre-selected deployed state to engage the substantially unfolded esophageal wall at the treatment location; and

delivering energy to an electrode of the electrode structure for treatment of the esophageal tissue.

2. The method for treating the esophagus according to claim 1, wherein measuring comprises calculating the esophageal luminal dimension at the treatment location of the esophagus based on the expansion of the sizing member.

3. The method for treating the esophagus according to claim 1, wherein expanding the sizing member comprises inflating a sizing balloon by introducing an expansion medium.

4. The method for treating the esophagus according to claim 2, wherein the expansion medium is a compressible fluid.

5. The method for treating the esophagus according to claim 2, wherein the expansion medium is an incompressible fluid.

6. The method for treating the esophagus according to claim 3, wherein calculating comprises determining the amount of the expansion medium introduced to the sizing balloon while it is inflated.

7. The method for treating the esophagus according to claim 6, wherein determining the amount of expansion medium comprises measuring the mass of the expansion medium introduced to the sizing balloon.

8. The method for treating the esophagus according to claim 6, wherein determining the amount of expansion medium comprises measuring the volume of the expansion medium introduced to the sizing balloon.

9. The method for treating the esophagus according to claim 6, wherein determining the amount of expansion medium comprises measuring an internal pressure exerted from the expansion medium using a pressure sensor coupled to the sizing balloon.

10. The method for treating the esophagus according to claim 9, wherein calculating further comprises determining the esophageal luminal dimension based on the measured amount of expansion medium introduced to the balloon at a given pressure.

11. The method for treating the esophagus according to claim 1, wherein measuring comprises determining the esophageal luminal dimension with ultrasound imaging.

12. The method for treating the esophagus according to claim 1, wherein measuring comprises determining the esophageal luminal dimension with infrared imaging.

13. The method for treating the esophagus according to claim 1, wherein measuring comprises determining the esophageal luminal dimension with calipers.

14. The method for treating the esophagus according to claim 3, wherein the expansion medium comprises a contrast medium, and wherein measuring comprises determining the esophageal luminal dimension with a fluoroscope.

15. The method for treating the esophagus according to claim 1, wherein the selecting step comprises choosing one electrode structure from an inventory of devices having different electrode deployment sizes.

16. The method for treating the esophagus according to claim 1, wherein deploying the selected electrode structure comprises inflating a balloon configured to expand the electrode structure.

17. The method for treating the esophagus according to claim 16, wherein deploying the electrode structure comprises inflating the balloon with an expansion medium.

18. The method for treating the esophagus according to claim 17, wherein deploying the selected electrode structure further comprises controlling inflation of the balloon to a pressure no greater than 7 psig by sensing pressure using a pressure sensor.

19. The method for treating the esophagus according to claim 18, wherein the balloon is inflated to a pressure between 4 psig and 7 psig.

20. The method for treating the esophagus according to claim 1, wherein the selected electrode structure comprises an array of electrodes.

21. The method for treating the esophagus according to claim 20, wherein delivering energy comprises applying radiofrequency energy to tissue of the esophagus through the array of electrodes, wherein the array of electrodes comprises a multiplicity of parallel bipolar electrode pairs having a width in the range from 0.1 mm to 3 mm, and are spaced-apart by a distance in the range from 0.1 mm to 3 mm.

22. A method for treating the tissue of an esophagus at a treatment location, the method comprising:

introducing an expandable sizing member at the treatment location within the esophagus;

substantially unfolding surface contours of a wall of the esophagus at the treatment location by expanding the sizing member;

measuring a substantially unfolded esophageal luminal dimension at the treatment location;

positioning an electrode deployment device at the treatment location within the esophagus, wherein the electrode deployment device has an electrode structure coupled to an expansion member;

deploying the expansion member to engage the electrode structure against a wall of the esophagus; and

delivering sufficient energy to the electrode structure for treatment of the esophageal tissue based on the unfolded esophageal luminal dimension at the treatment location.

23. The method for treating the esophagus according to claim 22, wherein the measuring step further comprises calculating the luminal dimension at the treatment location based expanding the sizing member.

24. The method for treating the esophagus according to claim 23, wherein expanding the sizing member comprises inflating a sizing balloon by introducing an expansion medium.

25. The method for treating the esophagus according to claim 24, wherein the expansion medium is a compressible fluid.

26. The method for treating the esophagus according to claim 24, wherein the expansion medium is an incompressible fluid.

27. The method for treating the esophagus according to claim 24, wherein calculating comprises determining the amount of the expansion medium introduced to the sizing balloon while it is inflated.

28. The method for treating the esophagus according to claim 27, wherein determining the amount of expansion medium comprises measuring the mass of the expansion medium introduced to the sizing balloon.

29. The method for treating the esophagus according to claim 27, wherein determining the amount of expansion medium comprises measuring the volume of the expansion medium introduced to the sizing balloon.

30. The method for treating the esophagus according to claim 27, wherein determining the amount of expansion medium comprises measuring an internal pressure exerted from the expansion medium using a pressure sensor coupled to the sizing balloon.

31. The method for treating the esophagus according to claim 30, wherein calculating further comprises determining the esophageal wall dimension based on the measured amount of expansion medium inside the balloon at a given pressure.

32. The method for treating the esophagus according to claim 22, wherein deploying the expansion member of the electrode deployment device comprises inflating the expansion member, wherein the expansion member comprises a balloon configured to expand to a range of diameters between 12 mm and 50 mm.

33. The method for treating the esophagus according to claim 32, wherein deploying the expansion member comprises inflating the balloon with an expansion medium.

34. The method for treating the esophagus according to claim 33, wherein inflating the expansion member comprises inflating the balloon to a pressure no greater than 10 psig.

35. The method for treating the esophagus according to claim 34, wherein the balloon is inflated to a pressure between 4 psig and 7 psig.

36. The method for treating the esophagus according to claim 22, wherein delivering energy comprises applying radiofrequency energy to tissue of the body lumen through electrodes of the electrode structure, wherein the electrodes comprise a multiplicity of parallel bipolar electrode pairs having a width in the range from 0.1 mm to 3 mm, and are spaced-apart by a distance in the range from 0.1 mm to 3 mm.

37. The method for treating the esophagus according to claim 36, wherein the radiofrequency energy density is delivered at a total dosage in the range from 1 joules/cm² to 50 joules/cm².

38. The method for treating the esophagus according to claim 37, wherein the radiofrequency energy is delivered over a time period below 5 seconds.